Three granulocyte donors were recruited since the last annual report. To date, 82 healthy volunteers were accrued and signed informed consent as active granulocyte donors and donated a total of 272 filgrastim- and dexamethasone-stimulated or filgrastim-alone stimulated granulocyte apheresis components since protocol started. 31 components were collected since last report. Up to 8/8/17 this year , these products were administered to 6 patients with severe neutropenia or neutrophil dysfunction and life-threatening infections; 3 had chronic granulomatous disease and 2 were patients transplanted for leukemia and 1 had an IL1-receptor defect. In total, 25 of 45 recipients had fungus or mold (an additional one could not be confirmed, and one of the patients had polymicrobial bacteremia in addition to fungus) and 19 had life-threatening bacterial infections, including two with carbapenem-resistant Klebsiella pneumonia. As was true this year, a median of 4 granulocyte transfusions (range 1 to 41) were administered per patient course since protocol inception. Since last annual report, 2 of 6 patients did not respond to the granulocyte transfusions (GTX) and died having received only 1 and 6 granulocytes transfusions each. The remaining 4 improved and were discharged having received a total of 24 GTX overall. Two CGD ( of the 6 patients) patients disountinued their course of GTX due to reactions/alloimmunizations. Donors experienced mild to moderate insomnia, nightmares, irritability and jitteriness related to the dexamethasone, and myalgia, arthralgias, fatigue and flushing related to the filgrastim administration. This year 14 donors underwent comprehensive eye exams for cataract detection as an assessment prior to repetitive dexamethasone administration. Donor retention in the program was 77%, with donor loss due to moving away from the Bethesda area or loss of interest. A mean of 7.2 liters were processed per procedure, during which 5.4 x 10e10 granulocytes (range 2.32-10.32 x 10e10) were collected in a volume of 335 mL. Granulocyte collection efficiency was only 39.1% using the Spectra apheresis device, with WBC differential composed of 87% granulocytes, and with a mean hematocrit of 12% and a mean red cell content of 39 mL. An abstract was submitted to ASH resulting from data analysis entitled Retrospective analysis on the effect of repeated stimulated granulocyte donation on hematopoietic indices in granulocyte donors and a paper to AABB entitled The effect of repeated stimulated granulocyte donations on hematopoietic indices in donors: a 24 year donor center experience Two protocol amendments were approved and are underway. (1) 26 subjects consented to Evaluation of bone mineral density in granulocyte donors and (2) 56 subjects consented to Assessment of renal function in granulocyte donors.
